NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients

March 20, 2024 updated by: Mikhail Y. Kirov, Northern State Medical University

Comparison of High Flow Oxygenation, Noninvasive Ventilation and Standard Oxygen Therapy in the Early Post-extubation Period in Patients With Acute Respiratory Distress Syndrome

The weaning failure is a paramount challenge when aggressive discontinuation of respiratory support in ARDS. The aim of the study is to improve weaning safety and efficacy by a transient postextubation non-invasive respiratory support.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

HFNO (high-flow nasal oxygenation and NIV (non invasive ventilation) are to be randomly compared in the ARDS postextubation period.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Arkhangelsk Region
      • Arkhangelsk, Arkhangelsk Region, Russian Federation, 163000
        • City hospital # 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

ARDS

Exclusion Criteria:

Severe ICU-aquired weakness Severe COPD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NIV
Non-invasive ventilation
Device: Respiratory support
High-flow nasal oxygenation
Other Names:
  • Oxygenation
Active Comparator: HFO
High Flow Oxygenation
Device: Respiratory support
High-flow nasal oxygenation
Other Names:
  • Oxygenation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weaning failure
Time Frame: 48 hrs
Weaning failure and re-intubation or recanulation
48 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WEAN_2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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